Benitec keeps BB-301 pivotal trial enrollment planned for mid-2027 after FDA feedback
Benitec Biopharma received FDA Type C meeting feedback seeking more information to support the design of its BB-301 pivotal study in Oculopharyngeal Muscular Dystrophy-related dysphagia. The company said the agency will review the added submission so that the final study plan can be set in Q1 2027, while patient enrollment remains targeted for mid-2027. Benitec also plans to disclose updated early-stage BB-301 results at a gene-therapy meeting in Hamburg in October.
Why it matters
The FDA request makes additional natural-history and other supporting data a prerequisite to locking the pivotal-study design. Benitec says the review timetable still supports enrollment beginning in mid-2027, making the upcoming clinical update and Q1 2027 design decision key milestones.
Key facts
- 1The FDA asked Benitec for further information, including data from its OPMD Natural History Study, for the proposed BB-301 pivotal trial. investing.com
- 2Benitec said it expects to finalize the pivotal-study design in Q1 2027 after the FDA reviews the additional submission. tradingview.com
- 3The company continues to plan BB-301 pivotal-trial enrollment for mid-2027. investing.com
- 4Benitec plans to present 12-month results from six Cohort 1 patients and interim data from three Cohort 2 patients at an October 27-30 meeting. investing.com
- 5BB-301 is being developed for swallowing impairment associated with Oculopharyngeal Muscular Dystrophy. investing.com
Summary written by AlphAI from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.